Exposure to Pharmaceuticals Present in the Environment
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Exposure to Pharmaceuticals Present in the Environment
Richard T. Williams, PhD Senior Research Fellow, Pharmaceutical Sciences, Pfizer Global Research and Development Groton, Connecticut Jon C. Cook, PhD Senior Director, Toxicology Sciences, Pfizer Global Research and Development, Groton, Connecticut
Key Words Environmental risk assessment; Pharmaceuticals; Exposure; Ecotoxicology Correspondence Address Richard T. Williams, MS 118A-2026, Pfizer Global Research and Development, Groton, CT 06340 (e-mail: richard.t.williams @pfizer.com). This article was the keynote presentation by Richard Williams at the Joint DIA/HESI/SAPS Conference on Environmental Assessment of Human Medicines, May 22–23, 2006, in Stockholm, Sweden.
Pharmaceuticals have been detected in the environment with increasing frequency since the late 1990s. The concentrations detected are low. For example, the average concentration of a pharmaceutical detected in surface waters is 0.042 parts per billion (µg/L) when the value for samples reported to contain nondetectable levels of an analyte is assumed to be 0 and 0.151 when these samples without detection are not included in the averaging. The bioactivity of pharmaceuticals has led to concerns that organisms in the environment may be impacted by ongoing exposure as a result of continuing patient use.
INTRODUCTION Low levels of pharmaceuticals are being detected in the environment with increasing frequency (Figure 1). These detections have resulted in increased scientific and regulatory scrutiny to evaluate the potential for pharmaceuticals to cause environmental effects. There is widespread agreement that the potential for chronic effects in aquatic organisms resulting from continuing exposure to low levels of bioactive drugs is the primary environmental concern associated with human medicines. The potential for acute exposures and ecotoxicity has been demonstrated to be low (1,2). Drugs are a chemically diverse group of substances (3), but the property of pharmacological bioactivity differentiates drugs and supports environmental evaluation of them as a distinct class. The presence of drugs in the environment has raised questions about the adequacy of (1) existing regulatory approaches to identify potential environmental impacts, (2) current environmental risk assessment (ERA) science, (3) available ecotoxicology data, and (4) societies’ understanding of the magnitude of the potential problem created by their presence. This article addresses the exposure of organisms in the environment to pharmaceuticals and
The appropriateness of the existing environmental science and data for answering key questions pertaining to the fate and effect of bioactive pharmaceuticals has been questioned. The objectives of this article are to describe the sources of human pharmaceuticals detected in the environment, provide a detailed summary of the worldwide detection data, evaluate the potential significance of the environmental concentrations reported, and propose a mechanistic approach to the exposure analysi
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